NCT04324086

Brief Summary

Recruited patients with necrotic pulp after application of Calcium hydroxide are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 24, 2020

Last Update Submit

March 25, 2020

Conditions

Effects of the Elements

Outcome Measures

Primary Outcomes (1)

  • change in post operative pain (Visual Analogue Scale)

    Numerical (0-10)

    Intrappointment at 4,24,48,72 and 96 hours

Study Arms (3)

XP-endo Finisher file

EXPERIMENTAL

removal of calcium hydroxide intracanal medication with XP-endo Finisher file

Device: Calcium hydroxide with XP-endo Finisher file

Irrisafe Ultrasonic tip

EXPERIMENTAL

removal of calcium hydroxide intracanal medication with passive ultrasonic irrigation

Device: Calcium hydroxide with Irrisafe Ultrasonic tip

side vented needle

ACTIVE COMPARATOR

removal of calcium hydroxide intracanal medication with conventional syringe irrigation

Device: Calcium hydroxide with side vented needle

Interventions

Calcium hydroxide with XP-endo Finisher fileDEVICE

XP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of calcium hydroxide

XP-endo Finisher file
Calcium hydroxide with Irrisafe Ultrasonic tipDEVICE

passive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in reemoval of calcium hydroxide

Also known as: passive ultrasonic irrigation
Irrisafe Ultrasonic tip
Calcium hydroxide with side vented needleDEVICE

conventional syringe irrigation with side vented needle (prime Dent, India) in removal of calcium hydroxide

Also known as: conventional syringe irrigation
side vented needle

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medically free patients.
  • Patient's age between 20-50 years.
  • Both sexes.
  • Necrotic pulp as indicated by thermal or electric pulp testing.
  • No history of previous endodontic treatment of the tooth.
  • Enough crown structure for adequate isolation.

You may not qualify if:

  • Pregnancy or lactation
  • Medically compromised patients
  • Previous endodontic therapy of the affected tooth.
  • Teeth diagnosed with vital pulp.
  • Teeth with periodontal pocket more than 3mm deep.
  • Teeth with abnormal anatomy or calcified canals.
  • Teeth with caries below the bony level (non-restorable tooth).
  • Immature teeth with open apices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and dental medicine, Minia University

Minya, Egypt

RECRUITING

Related Publications (3)

  • Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.

    PMID: 25598754BACKGROUND

  • Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.

    PMID: 23657409BACKGROUND

  • Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.

    PMID: 20647083RESULT

Central Study Contacts

Shaimaa Nasr El-din Abd El-Ghaffar, PHD

CONTACT

+0201020271788dr_shimes@hotmail.com

Reham Hassan, Ass.prof

CONTACT

01001542529reham-hassan@live.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phD student - Endodontic Department

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

April 1, 2020

Primary Completion

June 1, 2020

Study Completion

October 1, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share
Shared Documents
ICF, CSR

Locations

EG(1)